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HSA Approval

SALOFALK ENEMAS 4 g/60 ml

SIN10918P

SALOFALK ENEMAS 4 g/60 ml

SALOFALK ENEMAS 4 g/60 ml

May 6, 1999

DCH AURIGA SINGAPORE

DCH AURIGA SINGAPORE

Regulatory Information

DCH AURIGA SINGAPORE

DCH AURIGA SINGAPORE

Therapeutic

Prescription Only

Formulation Information

ENEMA

**4.2 Posology and method of administration** Posology Adults and elderly The following dosage guidelines are generally applicable: In patients with symptoms of acute inflammation, the content of 1 enema bottle (Salofalk 4 g/60 ml enemas) resp. 2 enema bottles (Salofalk 2 g/30 ml enemas) is administered into the intestine as an enema once daily at bedtime. Children There is little experience and only limited documentation for an effect in children. Method of administration Rectal use. The best results are achieved if the bowel is emptied before administration of the Salofalk enema. The desired therapeutic result can only be achieved if Salofalk enemas are used regularly and consistently. The duration of treatment is determined by the patient’s doctor. Acute attacks of ulcerative colitis usually regress after 8–12 weeks, after which Salofalk 2 g/30 ml / 4 g/60 ml enemas should not generally be used. Preparation - The bottle should be shaken for 30 seconds. - Then the protective cap of the applicator removed. - The bottle should be held at the top and bottom. The correct position for administration is as follows: - The patient should lie down on his/her left side with his/her left leg stretched out and right leg bent. This makes it easier for the enema to be administered and for the enema to be effective. Administration of the rectal suspension - The tip of the applicator should be inserted deep into the rectum. - The bottle should be tipped downwards slightly and then squeezed slowly. - Once the bottle is empty, the applicator tip should be slowly withdrawn from the rectum. - The patient should remain lying down in this position for at least 30 minutes to allow the contents of the enema to spread throughout the rectum. - If possible, the rectal suspension should be allowed to exert its effects all night.

RECTAL

Medical Information

**4.1 Therapeutic indications** Acute attacks of ulcerative colitis (a chronic inflammatory disease of the large bowel)

**4.3 Contraindications** Salofalk enemas must not be used in patients with - known hypersensitivity to the active substance, to salicylates or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ - severe impairment of hepatic or renal function

A07EC02

mesalazine

Manufacturer Information

DCH AURIGA SINGAPORE

Corden Pharma Fribourg AG, Zweigniederlassung Ettingen

Losan Pharma GmbH - Werk Neuenburg

Active Ingredients

MESALAZINE

4 g/60 ml

Mesalazine

Documents

Package Inserts

Salofalk enemas_PI.pdf

Approved: May 8, 2023

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